Vaxcyte

PCVX

Market cap $5.56B

New Agreement with Thermo Fisher Scientific Expands Domestic Capacity to Support Future Commercial Manufacturing of Vaxcyte's Broad-Spectrum Pneumococcal Conjugate Vaccine Candidates

Vaxcyte, Inc. (NASDAQ:PCVX ) Cantor Global Healthcare Conference 2025 September 3, 2025 2:45 PM EDT Company Participants Grant Pickering - Co-Founder, CEO & Director Andrew Guggenhime - President & CFO James Wassil - Executive VP & COO Conference Call Participants Carter Gould - Cantor Fitzgerald & Co., Research Division Presentation Carter Gould Research Analyst Okay. Good afternoon.

VAX-31 Optimized Dose, with Majority of Serotypes Dosed at 4.4mcg and Balance at 3.3mcg, is Designed to Elicit Even Stronger Immune Responses in Infant Population to Protect Against Invasive Pneumococcal Disease (IPD)

Vaxcyte (PCVX) Q2 Loss Widens 11%

Following Interactions with FDA on VAX-31 Adult Program, Including End-of-Phase 2 Meeting, Company Finalizing Phase 3 Clinical Program to Validate VAX-31 as Potential New Standard-of-Care Adult PCV ; Pivotal, Non-Inferiority Study Expected to be Initiated in Fourth Quarter of 2025 with Topline Data in 2026 FDA Provided Input on VAX-31 Adult CMC Licensure Requirements Facilitating Progression to Phase 3; Company Plans to Seek Ongoing Input as Program Advances Company Expects Multiple VAX-31 Adult Phase 3 Program Data Readouts in 2026 and 2027 to Support Biologics License Application Submission For VAX-31 Pediatric Program, Company Modifies Ongoing Infant Phase 2 Dose-Finding Study to Add a VAX-31 Optimized Dose Arm (4.4mcg/3.3mcg) and Discontinues Enrollment of Low Dose Arm; Enrollment in Modified Study Expected to Proceed by End of Third Quarter of 2025 with Topline Data from Both Primary Immunization Series and Booster Dose by End of First Half of 2027 Company Remains Focused on Disciplined Capital Allocation; Streamlining Early-Stage Pipeline to Prioritize Resources for PCV Programs and Further Extend Cash Runway Approximately $2.8 Billion in Cash, Cash Equivalents and Investments as of June 30, 2025 SAN CARLOS, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a business update, highlighting key clinical and regulatory progress for VAX-31, a potential best-in-class pneumococcal conjugate vaccine (PCV).

-- Company Reported Positive Topline Safety, Tolerability and Immunogenicity Data from Phase 2 Dose-Finding Study of VAX-24 in Healthy Infants; Balance of Data Expected by End of 2025 -- -- Initiated Second and Final Stage of VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Three-Dose Immunization Series Expected in Mid-2026, With Complete Booster Data Up to Nine Months Later --

SAN CARLOS, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced it has appointed Dr. Olivier Brandicourt, a veteran biopharmaceutical industry executive and the former Chief Executive Officer of Sanofi S.A., to its Board of Directors.

The downside comes after PCVX reports mixed results from a mid-stage study on its pneumococcal vaccine in infants.

The decline in biotech stocks comes after FDA official Peter Marks' resignation, citing irreconcilable differences with the new HHS Secretary.

Dr. Kavita Patel joins 'Fast Money' to talk the impact of FDA and HHS changes on vaccines, public health policy, and more.